The business of DNA
is undergoing a revolution. We can already get our genes scanned for the bargain-basement price of $99. Soon we’ll be able to have
entire genomes sequenced for less than the cost of a MacBook Air. That’s huge
considering that not so long ago it cost billions of dollars to
map a single genome.

But the ability of
scientists, doctors and companies to tell us how our genes might impact our
health now hinges on a case being debated by the U.S. Supreme Court, the infamously drawn-outAssociation for Molecular Pathology
v. Myriad Genetics. The case dates back to a 2009 lawsuit filed by the
American Civil Liberties Union and centers on the question of whether genes —
those snippets of DNA that encode the proteins inside cells — can be
patented. The ACLU and the scientists, advocacy organizations and patients it
represents say no because a gene is something that exists in nature, just like a
leaf, an oxygen molecule or gold. Myriad Genetics told the Court its inventors had created a new,
never-before-seen molecule.

Some of the justices don’t seem to buy Myriad’s argument,
sparking some hope in the genomics and personalized medicine communities that
when the Court finally decides the case — probably in late June — they’d have
reason to celebrate.

“What we’re arguing about is really the future of medicine and
either accelerating it or slowing it down,” says Dietrich Stephan, the CEO of SV
Bio and founder of Navigenics. “[Gene patenting] turned into this quagmire that
was holding the field back.

“We need to be able to instantaneously deliver that information
to [patients] and their doctors and not go through all these crazy hoops of
paying the license holder.”

The real value and potential for innovation, experts say, comes
after genes or gene mutations are identified, and that genetic insight is then
applied to a new process, method or algorithm. In most cases, those new
processes, methods or algorithms would still be patentable, but not the
underlying genetic code.

Diagnostic and therapeutic companies would compete on the
quality and price of their tests instead of having a monopoly on the entire
pipeline, as Myriad does now with its patents on BRCA1 and BRCA2, two genes
associated with early-onset breast and ovarian cancers. Women who want to be
tested for these genes have to take Myriad’s test, which can cost several
thousand dollars.

As it stands now,
the patent-happy U.S. Patent and Trademark Office has doled out thousands of
gene patents since the early 1980s, many of which cover human genes. Myriad
Genetics is not the only organization that holds these kinds of patents. 23andMe, Incyte Genomics, Genentech, Harvard, MIT and the
University of California are but a few of the institutions that have held or
continue to hold gene patents. Some of the patents don’t require licensing fees
and are pretty open. Others are locked up tight. Run afoul of the wrong gene
patent, and you can expect a lawyer to get involved.

Myriad has sent
researchers cease-and-desist orders and Harvard and MIT have filed lawsuits. All of which hampers the progress of
scientific research, says Rochelle Dreyfuss, a professor at the New York
University School of Law who specializes in intellectual property law and
science. “In order to do a full sequence for a person, you might have to get
permission from all of them,” says Dreyfuss.”That’s a lot of different people,
and any one person could just say no.”

That defeats the purpose — and potential — of whole-genome
sequencing, and in a way, robs patients of their right to know their own
genetics, a point the Association for Molecular Pathology has made in the past,
says Dreyfuss. Their argument is that people have a First Amendment right to
know the information inside their own bodies, but “the courts have never ruled
on that issue,” she said.

Like the
pharmaceutical industry, Myriad and others argue that without the ability to
patent genes, patients might be worse off. Lacking financial incentives,
companies might not be willing to put in the years and millions of dollars it
can take to make these kinds of advances, a point some of the Justices seemed to recognize this week. Whether that’s true or not is
debatable.

“In the drug space, people have very clearly figured out that
the most airtight patents are around the molecules themselves,” says SV Bio’s
Stephan. “Even if that molecule targets a gene, no one would argue that you’d
need to have the gene patented in order for that patent to stand on its own.” We
should take that model and apply it to diagnostics, he says, where the
patentable discoveries are not genes, but new test kits that probe for genetic
conditions or predispositions to certain diseases better and faster than
previous technologies. That’s how you foster innovation and how you assuage the
field that the market is going to be okay, Stephan argues.

Whatever the Court decides this summer, one thing is clear:
this case is only the beginning of the debate around who owns what genetic
information, says Stanford’s Drew Endy, a bioengineer and an advocate of
open-source biotechnology. In the future, scientists, doctors, companies and
lawyers will have to grapple not only with gene sequences, but “what you can use
the sequence to do.” That, he says, takes us into the brave new world of genetic
copyright law, and if the music and software industries have taught us anything,
it’s going to be a very long, uncomfortable ride.